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A Comparative Study of Percutaneous Pulsed Field Ablation Guided by Ultrasound Alone Versus Fluoroscopy in Patients With Atrial Fibrillation

11. August 2026 aktualisiert von: China National Center for Cardiovascular Diseases
This prospective, randomized, multicenter, open-label, non-inferiority interventional study aims to compare the therapeutic efficacy of percutaneous pulsed field ablation (PFA) guided by ultrasound alone versus fluoroscopy in patients with paroxysmal atrial fibrillation (AF). The success rate of complete electrical isolation of pulmonary veins during the procedure was compared to verify that ultrasound-only guidance is non-inferior to fluoroscopic guidance.

Studienübersicht

Status

Noch keine Rekrutierung

Bedingungen

Intervention / Behandlung

Studientyp

Interventionell

Einschreibung (Geschätzt)

276

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Erwachsene
  • Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Nein

Beschreibung

Inclusion Criteria:

  • Adult patients aged 18 to 75 years (including 18 years and 75 years of age).
  • Patients diagnosed with paroxysmal atrial fibrillation via 12-lead electrocardiography or ambulatory electrocardiography and scheduled to undergo pulsed field ablation.
  • Subjects are able to understand the purpose of the study, voluntarily participate in the study and sign the informed consent, and are willing to complete the follow-up according to the requirements of the program.

Exclusion Criteria:

  • Atrial fibrillation secondary to electrolyte imbalance, thyroid disorders, or reversible non-cardiac causes;
  • Previous history of catheter ablation or cardiac surgery for atrial fibrillation;
  • Prior surgical history including patent foramen ovale closure, atrial septal defect closure or repair;
  • Implantation of left atrial appendage occluder, mechanical mitral valve prosthesis, or valvuloplasty ring containing metallic materials;
  • Concomitant other tachyarrhythmias requiring catheter ablation (e.g., atrioventricular reentrant tachycardia, atrioventricular nodal reentrant tachycardia, atrial tachycardia, atrial flutter, Wolff-Parkinson-White syndrome, etc.);
  • Persistent atrial fibrillation;
  • Left atrial anteroposterior diameter (LAD) > 55 mm on transthoracic echocardiography;
  • Women who are pregnant, breastfeeding, or of childbearing age with plans to become pregnant during the clinical trial;
  • Current participation in another pharmaceutical or medical device clinical study.

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: Percutaneous pulsed field ablation performed under ultrasound-only guidance.
Percutaneous pulsed field ablation is performed under ultrasound-only guidance in patients with paroxysmal atrial fibrillation.
Verfahren: Percutaneous pulsed field ablation is performed under ultrasound-only guidance in patients with paroxysmal atrial fibrillation.
Percutaneous pulsed field ablation is performed under ultrasound-only guidance in patients with paroxysmal atrial fibrillation.
Aktiver Komparator: Pulsed field ablation performed under fluoroscopic guidance
Patients with paroxysmal atrial fibrillation underwent percutaneous pulsed field ablation under fluoroscopic guidance.
Verfahren: Patients with paroxysmal atrial fibrillation underwent percutaneous pulsed field ablation under fluoroscopic guidance.
Patients with paroxysmal atrial fibrillation underwent percutaneous pulsed field ablation under fluoroscopic guidance.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Success rate of complete electrical isolation of pulmonary veins during the procedure
Zeitfenster: Immediately post-procedure
The proportion of all pulmonary veins maintaining bidirectional block across ablation lines at 20 minutes after ablation completion.
Immediately post-procedure

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
The incidence of complications within 30 days after the procedure
Zeitfenster: Within 30 days post-procedure
Observe the proportion of complications occurring within 30 days after the procedure. Such complications include pericardial effusion or cardiac tamponade requiring drainage, phrenic nerve palsy lasting more than 24 hours, severe vascular complications requiring intervention, stroke/transient ischemic attack, atrioesophageal fistula, and death.
Within 30 days post-procedure
Success rate of atrial fibrillation ablation at 12 months post-procedure.
Zeitfenster: 12 months post-procedure
Defined as the absence of AF, atrial flutter (AFL), or atrial tachycardia (AT) episodes ≥30 seconds on dynamic electrocardiogram (ECG) monitoring after the blanking period (90 days post-catheter ablation)
12 months post-procedure
The proportion of patients admitted to hospital or emergency departments due to atrial fibrillation recurrence within 12 months after the procedure.
Zeitfenster: 12 months post-procedure
The proportion of patients admitted to hospital or emergency departments due to atrial fibrillation recurrence within 12 months after the procedure.
12 months post-procedure
The proportion of patients who received electrical cardioversion due to atrial fibrillation recurrence within 12 months after the procedure
Zeitfenster: 12 months post-procedure
The proportion of patients who received electrical cardioversion due to atrial fibrillation recurrence within 12 months after the procedure.
12 months post-procedure
The proportion of patients undergoing repeat ablation surgery owing to atrial fibrillation within 12 months after the procedure
Zeitfenster: 12 months post-procedure
The proportion of patients undergoing repeat ablation surgery owing to atrial fibrillation within 12 months after the procedure
12 months post-procedure
The proportion of patients who resumed antiarrhythmic drug therapy during follow-up after the blanking period
Zeitfenster: From the end of the blanking period (within 90 days after catheter ablation) to 12 months post-procedure
The proportion of patients who resumed antiarrhythmic drug therapy during follow-up after the blanking period
From the end of the blanking period (within 90 days after catheter ablation) to 12 months post-procedure
Improvement in the total EQ-5D quality-of-life questionnaire score at 12 months post-procedure compared with baseline
Zeitfenster: 12 months post-procedure
The degree of improvement in total EQ-5D scores at 12 months after ablation relative to baseline levels
12 months post-procedure
Statistical analysis was performed to evaluate differences in fluoroscopic exposure dose between the two groups.
Zeitfenster: Immediately post-procedure
Statistical analysis was performed to evaluate differences in fluoroscopic exposure dose between the two groups.
Immediately post-procedure
Compare the length of hospital stay and postprocedural ICU/CCU stay duration between the two groups.
Zeitfenster: through study completion, an average of 1 year
After hospital discharge, the length of hospital stay for this admission and the duration of postoperative observation in CCU/ICU were compared between the two groups of patients.
through study completion, an average of 1 year
Compare the procedural time and DSA fluoroscopy time between the two groups.
Zeitfenster: Immediately post-procedure
Statistical analyses were performed to compare procedural duration and DSA fluoroscopy duration across the two groups.
Immediately post-procedure
Compare the differences in costs between the two groups, including medical equipment costs, personnel costs, and patient hospitalization expenses.
Zeitfenster: through study completion, an average of 1 year
Total hospitalization costs incurred during this admission were compared between the two groups after hospital discharge.
through study completion, an average of 1 year

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

China National Center for Cardiovascular Diseases

Mitarbeiter

Hangzhou Dinova EP Technology Co., Ltd

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Geschätzt)

15. August 2026

Primärer Abschluss (Geschätzt)

28. Februar 2029

Studienabschluss (Geschätzt)

28. Februar 2029

Studienanmeldedaten

Zuerst eingereicht

29. Juli 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

11. August 2026

Zuerst gepostet (Tatsächlich)

13. August 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

13. August 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

11. August 2026

Zuletzt verifiziert

1. Juli 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • 2026-3078

Plan für individuelle Teilnehmerdaten (IPD)

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NEIN

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

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